Following more than two months of testimonies, a federal jury will this week begin deliberating in the trial of Barry J. Cadden, head pharmacist and co-owner the former New England Compounding Center (NECC), which is accused of causing the multi-state fungal meningitis outbreak in the US in 2012.
The meningitis outbreak sickened hundreds of individuals and resulted in the deaths of more than 60 people. Prosecutors have charged Cadden with 25 of those deaths.
US District Judge Richard Stearns said to the Boston federal court that he will let jurors decide whether Cadden was responsible for causing those deaths.
Prosecutors allege that the Center used expired ingredients and failed to follow industry cleanliness standards, resulting in tainted steroid injections. He has also been charged with other offences under federal racketeering laws.
Lawyers for Cadden have argued that no “reasonable jury” could convict him of second-degree murder based on the evidence that was introduced in the trial and that the judge should dismiss the charges relating to those murders.
A US$200 million settlement was reached in 2015 between NECC, the companies with which it did business, and those people injured by the injections and families of those that died. Victims may also receive compensation through civil lawsuits.
The FDA has already issued new guidelines for compounding pharmacies; In April 2016, the FDA issued three new Compounding Guidance Documents. The FDA was also granted more authority to regulate and monitor the manufacturing of compounding drugs.
Fungal contamination in relation to sterile drug recalls represents the second-most common form of microbiological contamination. Learn more about cleanroom best practice and preventing sterility issues at the Cleanroom Technology Conference.
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